From: Neurological and psychiatric safety of tafenoquine in Plasmodium vivax relapse prevention: a review
Adverse event, n (%) | TQ + CQ | PQ + CQ (N = 50) | Placebo + CQ (N = 54) | |||
---|---|---|---|---|---|---|
50 mg (N = 55) | 100 mg (N = 57) | 300 mg (N = 57) | 600 mg (N = 56) | |||
Any nervous system disorder | 17 (31) | 17 (30) | 13 (23) | 16 (29) | 17 (34) | 21 (39) |
 Headache | 14 (25) | 17 (30) | 10 (18) | 16 (29) | 14 (28) | 20 (37) |
 Dizziness | 7 (13) | 2 (4) | 5 (9) | 4 (7) | 5 (10) | 5 (9) |
 Migraine | 0 | 0 | 0 | 0 | 0 | 1 (2) |
 Tremor | 0 | 0 | 1 (2) | 1 (2) | 0 | 0 |
 Paraesthesia | 0 | 0 | 0 | 1 (2) | 0 | 0 |
 Sciatica | 0 | 1 (2) | 0 | 0 | 0 | 0 |
 Burning sensation | 1 (2) | 0 | 0 | 0 | 0 | 0 |
 Syncope | 0 | 0 | 0 | 0 | 1 (2) | 0 |
 Dysaesthesia | 0 | 0 | 0 | 0 | 1 (2) | 0 |
Any psychiatric disorder | 2 (4) | 3 (5) | 5 (9) | 3 (5) | 1 (2) | 1 (2) |
 Insomnia | 2 (4) | 3 (5) | 5 (9) | 3 (5) | 3 (6) | 1 (2) |
 Tic | 0 | 0 | 0 | 1 (2) | 0 | 0 |
Expanded termsa | ||||||
 Asthenia | 5 (9) | 4 (7) | 1 (2) | 5 (9) | 0 | 0 |
 Fatigue | 0 | 1 (2) | 1 (2) | 0 | 0 | 0 |